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Materialise NV

Belgium·BE-MF-000000034

Last updated September 17, 2026

Information

Country
Belgium
Address
15, Technologielaan, Leuven, Belgium
LinkedIn
—
Facebook
—
Phone
+32 16 39 66 11
PRRC Contact
Jan Demol
EUDAMED SRN
BE-MF-000000034
FDA FEI Number
—
DUNS Number
373139427

Catalogue (526)

Page 11 of 11
DeviceModel / ReferenceRegistriesClassStatus
Ct-Modeller System K970617
FDA 510(k)
Class IIActive
Materialise TKA Guide System K221337
FDA 510(k)
Class IIActive
Materialise Glenoid Positioning System K190286
FDA 510(k)
Class IIActive
Zimmer Patient Specific Instruments System K121640
FDA 510(k)
Class IIActive
Materialise TKA Guide System K251554
FDA 510(k)
Class IIActive
Mimics Thoracic Planner K251964
FDA 510(k)
Class IIActive
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner K220452
FDA 510(k)
Class IIActive
Zimmer Patient Specific Instruments Planner K112301
FDA 510(k)
Class IIActive
Materialise TKA Guide System K173445
FDA 510(k)
Class IIActive
Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planne K113829
FDA 510(k)
Class IIActive
SurgiCase Viewer K213684
FDA 510(k)
Class IIActive
3matic K060950
FDA 510(k)
Class IIActive
Mimics Cardiac Planner K233217
FDA 510(k)
Class IIActive
TruMatch CMF Titanium 3D Printed Implant K173039
FDA 510(k)
Class IIActive
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K231112
FDA 510(k)
Class IIActive
Materialise Glenoid Positioning System K170893
FDA 510(k)
Class IIActive
Simplant System K033849
FDA 510(k)
Class IIActive
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K212569
FDA 510(k)
Class IIActive
Surgicase Connect K113599
FDA 510(k)
Class IIActive
Signature Planner, Signature Guides K140257
FDA 510(k)
Class IIActive
Materialise PKA Guide System K173970
FDA 510(k)
Class IIActive
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K241143
FDA 510(k)
Class IIActive
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K242813
FDA 510(k)
Class IIActive
Surgicase Cmf, Surgicase Connect, Surgicase Guide K103136
FDA 510(k)
Class IIActive
Simplant Dr. James K053592
FDA 510(k)
Class IIActive
Signature Planner, Signature Guides K111863
FDA 510(k)
Class IIActive

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